Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

• Drug: placebo
  
  Randomization 2:1 treatment to placebo
• Drug: varenicline (CP-526,555)
  
  One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
  Other Name: Chantix, Champix

• Placebo Comparator: Placebo Arm
  
  Randomization 2:1 treatment to placebo
  Intervention: Drug: placebo
• Active Comparator: Treatment Arm
  
  Intervention: Drug: varenicline (CP-526,555)

Inclusion Criteria:

• Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
• Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
• Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria:

• PANSS score >70 at Screen or Baseline Visit.
• Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
• Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
• Subjects taking Bupropion.